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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2011-05-09Z-2675-2011TerminatedProduct labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.—clearance family
2011-05-09Z-2676-2011TerminatedProduct labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.—clearance family
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2015-07-24NAINo action indicatedVBM Medizintechnik GmbH0
2015-07-24NAINo action indicatedVBM Medizintechnik GmbH0
2010-12-07WLWarning LetterVBM Medizintechnik GmbH—
2010-12-07WLWarning LetterVBM Medizintechnik GmbH—
2010-06-10OAIOfficial action indicatedVBM Medizintechnik GmbH12
2010-06-10OAIOfficial action indicatedVBM Medizintechnik GmbH12
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